Physiological Response to 5 Days Fasting

Physiological Response to Prolonged Fasting in Healthy Volunteers

To investigate energy metabolism, anthropometry, blood pressure, gut microbiome, serum metabolome, glucose variability and neural mechanisms of food choice and mood before and after 5 days of fasting as well as their persistence in healthy men and women.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: Buchinger fasting

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13125
    • Charite Universitatsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men and women
• 20-50 years
• Body mass index 20-30 kg/m2

Exclusion Criteria:

• Clinically relevant heart, lung, liver, and kidney diseases
• Any prescribed medication (except for oral contraceptives)
• Current or chronic infection
• Intake of antibiotics within 6 months before study entry
• Fasting week within 6 months before study entry
• Habitual use of dietary supplements
• Food intolerances
• Pregnancy, lactation
• Vegan diet
• Smokers
• In addition for fMRI: sensorineural hearing loss, tinnitus, metal implants, electric devices

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fasting; Starts immediately with 5 days of Buchinger fasting	Other: Buchinger fasting; Caloric intake of < 250 kcal/d for 5 days
Placebo Comparator: Waiting list control; Starts with 5 days of Buchinger fasting after a waiting period of 12 weeks	Other: Buchinger fasting; Caloric intake of < 250 kcal/d for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting Energy Expenditure	Measured by indirect calorimetry (kcal/d)	6-th day of fasting compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting Energy Expenditure - Recovery	Measured by indirect calorimetry (kcal/d)	12 weeks after fasting compared to baseline
Resting Respiratory Exchange Ratio	Measured by indirect calorimetry	6-th day of fasting and 28 days after fasting compared to baseline
Office systolic blood pressure	Mean of five consecutive blood pressure measurements (mmHg)	6-th day of fasting and 12 weeks after fasting compared to baseline
Office diastolic blood pressure	Mean of five consecutive blood pressure measurements (mmHg)	6-th day of fasting and 12 weeks after fasting compared to baseline
Fecal microbiome composition	Measured by 16S Sequencing	6-th day of fasting and 12 weeks after fasting compared to baseline
Fecal and serum metabolome	Measured by mass spectrometry	6-th day of fasting and 12 weeks after fasting compared to baseline
Change in immune cell phenotypes	Peripheral blood effector T cell frequencies (Percent)	6-th day of fasting and 12 weeks after fasting compared to baseline
Glucose variability	Measured by continuous glucose monitoring over 14 days	From 3 days before until 6 days after fasting
Neural correlates of emotion processing	Measured by functional Magnetic Resonance Imaging	6-th day of fasting and 12 weeks after fasting compared to baseline
Neural correlates of food-specific delay discounting	Measured by functional Magnetic Resonance Imaging	6-th day of fasting and 12 weeks after fasting compared to baseline
Perceived Stress Questionaire (PSQ)	Range 0-100, with 0 indicating no perceived stress	6-th day of fasting and 12 weeks after fasting compared to baseline
Perceived Self Efficiency	Range 10-40, with 40 indicating highest self efficiency	6-th day of fasting and 12 weeks after fasting compared to baseline
PANAS Positive Affect Subscale (GESIS Panel)	Range 10-50, with 50 indicating highest positive affect	6-th day of fasting and 12 weeks after fasting compared to baseline
PANAS Negative Affect Subscale (GESIS Panel)	Range 10-50, with 50 indicating highest negative affect	6-th day of fasting and 12 weeks after fasting compared to baseline
International Physical Activity Questionaire (IPAQ, long version)	Time for moderate and vigorous activity (hours, minutes)	6-th day of fasting and 12 weeks after fasting compared to baseline

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Anja Mähler, PhD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): December 14, 2022
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: LEANER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No